Intends to Apply for and Receive FDA 510(k) Approval in 2008
Vicor Technologies, Inc. (OTCBB: VCRT),reviewed strategies and developments to (i) commercialize its patenteddevice, the PD2i Cardiac Analyzer, for risk stratification of patients forSudden Cardiac Death (SCD); (ii) its collaboration with the U.S. Army toassess severity of injury, and probability of survival, for criticallyinjured combat casualties and critically ill civilian patients and (iii)other milestones at its Annual Meeting of Stockholders today in Boca Raton,Florida.
Vicor President and CEO, Mr. David H. Fater, discussed the exciting, andrapid, developments with the U.S. Army's Institute of Surgical Research,since signing a Collaborative Research and Development Agreement in January2008.
Importantly, Mr. Fater noted that this effort could lead to a U.S. FDA510(k) device approval late this year of Vicor's PD2i to triage woundedsoldiers which can also be used in both military and civilian applicationsin the assessment of trauma victims, which would be a significant milestonein Vicor's history.
The collaborative effort is envisioned to lead to the development of newcomprehensive decision support tools, and or devices that may incorporatethe PD2i algorithm alone, or in association with other metrics currentlyunder investigation, with the goal to monitor, assess status and predictoutcome in critically injured humans. The study is entitled "Prediction ofInjury Severity and Outcome in the Critically Ill Using the PointCorrelation Dimension Algorithm."
Mr. Fater discussed with shareholders management's strategies to maintainVicor 's state-of-the-art platform technology leadership in riskstratification diagnosis, and to position the company to initiatecommercialization of its PD2i device for trauma and emergency response in2008, anticipating FDA 510(k) approval. Vicor would also seek to get CEMark approval in the European Union for the PD2i.
The status of Vicor's progress of its VITAL Trial, to risk stratifyindividuals for Sudden Cardiac Death (SCD), and the related applicationseeking FDA 510(k) approval for its PD2i Cardiac Analyzer, was reviewed indetail. Vicor believes its PD2i accurately risk stratifies patients whoare at high or low risk of suffering SCD within a six-month time frame, andwho may need a costly Implantable Cardioverter Defibrillator (ICD).
Mr. Fater emphasized that the issue of ICD implantation and riskstratification is extremely important to the Company since Vicor isconfident it is in the right place at the right time with the PD2i CardiacAnalyzer. He offered as support a recent Wall Street Journal article inwhich a Duke University cardiologist described the diagnostic situation forSCD as in 'chaos.'
In order to solidify Vicor's place in risk stratification technology, fournew members have been added to Vicor's Scientific Advisory Board (SAB)since July 2007 when Vicor became a public company.
In October, Edward F. Lundy, M.D., Ph.D., a Cardiothoracic Surgeon with aPh.D. in Physiology, with a primary focus on altered-state physiologiessuch as hibernation joined the SAB. Mr. Fater noted his background in bothcardiology and altered-state physiologies provides him with a uniqueperspective with which to assist Vicor in the expansion of several of itsplatform technologies.
In April 2008, Dr. Robert Hauser, Senior Consulting Cardiologist at theMinneapolis Heart Institute and Chairman of the Cardiovascular ServicesDivision at the Abbott Northwestern Hospital, joined the SAB. Hisbackground includes being the CEO of Cardiac Pacemakers, Inc. from1988-1992, then a subsidiary of Eli Lilly, later acquired by GuidantCorporation. His background as a physician and inventor of implantablecardiac devices provides him with a unique perspective with which to assistVicor in the expansion and commercialization of the PD2i Cardiac Analyzerplatform technology. Dr. Hauser holds multiple patents in the field ofimplantable cardiac devices.
In May, Dr. Jonathan Kaplan, Medical Director for Fidelis Care New York,one of the largest government program-based health plans in New York state,providing managed health care coverage for 350,000 Medicaid, Child HealthPlus and Family Health Plus members, joined the SAB. Mr. Fater noted hisbackground, both as a physician and medical director in a managed careenvironment, provides a unique payor perspective with which to assist Vicorin its commercialization and expansion.
In early June, Mr. Chazanovitz, currently serving as President, CEO and aDirector of Alveolus, Inc., a medical device company, and who previouslyserved as CEO of Cambridge Heart, Inc., a publicly traded company andcompetitor of Vicor, from February 2001-October 2006 also joined the SAB.Mr. Fater noted that his background in the medical device industry, ingeneral, and with Cambridge Heart, in particular, provides Mr. Chazanovitzwith a unique perspective with which to assist Vicor in thecommercialization and expansion of its platform technology.
